Article type
Abstract
Background: In Brazil, the Ministry of Health, and the National Committee for Health Technology Incorporation (CONITEC) regulate health technologies within the Public Health System (SUS), requiring regulatory approval, efficacy, effectiveness, safety, economic analysis, and relevance to the healthcare system. Stroke, particularly ischemic stroke (IS), significantly contributes to global mortality and disability, with Brazil reporting an annual incidence of 108 per 100,000, 75%-85% of which are cases of IS. In 2020, IS was responsible for 22,100 hospitalizations and 3,388 deaths. Discussions on mechanical thrombectomy (MT) for IS, previously approved for a more limited symptom window, have progressed towards extending its therapeutic window from 6 to 24 hours after potential benefits were presented.
Objectives: This study aimed to evaluate the cost-effectiveness, efficacy, and safety of MT in combination with optimal clinical care (OCC) for treating large vessel occlusion in IS beyond 8 hours and up to 24 hours, compared to OCC alone.
Methods: Supported by the Ministry of Health, the Cochrane Brazil Health Technology Assessment Center conducted an economic evaluation and a thorough review of the research, adhering to both Cochrane and Ministry of Health methodological guidelines.
Results: The analysis of two randomized clinical trials (RCTs) suggested that MT, in conjunction with OCC, likely enhances functional independence for IS patients within a 6–24-hour symptom window, without increasing the risk of mortality or severe hemorrhagic complications compared to OCC alone. Economic evaluations, incorporating data from the national RESILIENT study and RCTs, indicated that despite a significant budgetary impact, MT with OCC is cost-effective ($2,056.21 per QALY), supporting its broader implementation in the SUS.
Conclusions: Considering our analysis, in 2021, the Ministry of Health decided to extend the use of MT in the SUS for acute IS patients with symptom onset windows of 8–24 hours. Endorsed by the 2023 Clinical Protocol and Therapeutic Guidelines for IS, MT is recognized as a safe, effective, and cost-efficient approach for patients with significant vessel occlusion, emphasizing its importance for public health.
Objectives: This study aimed to evaluate the cost-effectiveness, efficacy, and safety of MT in combination with optimal clinical care (OCC) for treating large vessel occlusion in IS beyond 8 hours and up to 24 hours, compared to OCC alone.
Methods: Supported by the Ministry of Health, the Cochrane Brazil Health Technology Assessment Center conducted an economic evaluation and a thorough review of the research, adhering to both Cochrane and Ministry of Health methodological guidelines.
Results: The analysis of two randomized clinical trials (RCTs) suggested that MT, in conjunction with OCC, likely enhances functional independence for IS patients within a 6–24-hour symptom window, without increasing the risk of mortality or severe hemorrhagic complications compared to OCC alone. Economic evaluations, incorporating data from the national RESILIENT study and RCTs, indicated that despite a significant budgetary impact, MT with OCC is cost-effective ($2,056.21 per QALY), supporting its broader implementation in the SUS.
Conclusions: Considering our analysis, in 2021, the Ministry of Health decided to extend the use of MT in the SUS for acute IS patients with symptom onset windows of 8–24 hours. Endorsed by the 2023 Clinical Protocol and Therapeutic Guidelines for IS, MT is recognized as a safe, effective, and cost-efficient approach for patients with significant vessel occlusion, emphasizing its importance for public health.